Trial Outcomes & Findings for A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes (NCT NCT04591626)

Last Updated: 2023-05-24

Results Overview

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Oral Antihyperglycemic Medications (OAM) use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

291 participants

Primary outcome timeframe

Baseline, Week 28

Results posted on

2023-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	1.5 Milligrams (mg) Dulaglutide Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.	Placebo Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Overall Study STARTED	144	147
Overall Study Received At Least One Dose of Study Drug	144	147
Overall Study COMPLETED	134	142
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	1.5 Milligrams (mg) Dulaglutide Participants received 1.5 mg Dulaglutide administered once weekly (QW) subcutaneously (SC) as add-on to titrated treat-to-target (TTT) dose of Insulin Glargine given SC, along with metformin and/or acarbose.	Placebo Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Overall Study Adverse Event	4	0
Overall Study Withdrawal by Subject	5	3
Overall Study Physician Decision	0	1
Overall Study Death	0	1
Overall Study Non-Compliance with Study Drug	1	0

Baseline Characteristics

Participants with non-missing baseline value for HbA1c.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1.5 mg Dulaglutide n=144 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=147 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Total n=291 Participants Total of all reporting groups
Age, Continuous	57.80 years STANDARD_DEVIATION 9.33 • n=144 Participants	58.30 years STANDARD_DEVIATION 9.48 • n=147 Participants	58.10 years STANDARD_DEVIATION 9.39 • n=291 Participants
Sex: Female, Male Female	52 Participants n=144 Participants	57 Participants n=147 Participants	109 Participants n=291 Participants
Sex: Female, Male Male	92 Participants n=144 Participants	90 Participants n=147 Participants	182 Participants n=291 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	144 Participants n=144 Participants	147 Participants n=147 Participants	291 Participants n=291 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Race (NIH/OMB) Asian	144 Participants n=144 Participants	147 Participants n=147 Participants	291 Participants n=291 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Race (NIH/OMB) Black or African American	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Race (NIH/OMB) White	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Race (NIH/OMB) More than one race	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=144 Participants	0 Participants n=147 Participants	0 Participants n=291 Participants
Region of Enrollment China	144 Participants n=144 Participants	147 Participants n=147 Participants	291 Participants n=291 Participants
Hemoglobin A1c (HbA1c)	8.60 Percentage of HbA1c STANDARD_DEVIATION 1.00 • n=136 Participants • Participants with non-missing baseline value for HbA1c.	8.58 Percentage of HbA1c STANDARD_DEVIATION 0.97 • n=145 Participants • Participants with non-missing baseline value for HbA1c.	8.59 Percentage of HbA1c STANDARD_DEVIATION 0.98 • n=281 Participants • Participants with non-missing baseline value for HbA1c.

PRIMARY outcome

Timeframe: Baseline, Week 28

Population: All randomized participants with baseline and at least one post-baseline HbA1c data.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=133 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=142 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Change From Baseline in Hemoglobin A1c (HbA1c)	-2.03 Percentage of HbA1c Standard Error 0.076	-1.08 Percentage of HbA1c Standard Error 0.073

SECONDARY outcome

Timeframe: Week 28

Population: All randomized participants with baseline and at least one post-baseline HbA1c data.

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Odds Ratio (OR) was determined using longitudinal logistic regression model with Baseline HbA1c value + OAM use + Treatment + Visit + Treatment\*Visit as variables.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=133 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=142 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Percentage of Participants Achieving HbA1c <7.0%	75.9 Percentage of participants	33.8 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 28

Population: All randomized participants with baseline and at least one post-baseline body weight data.

Change from baseline in body weight was reported here. LS mean was determined by MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=133 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=142 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Change From Baseline in Body Weight	-0.76 kilogram (kg) Standard Error 0.224	0.42 kilogram (kg) Standard Error 0.217

SECONDARY outcome

Timeframe: Baseline, Week 28

Population: All randomized participants with baseline and at least one post-baseline fasting serum glucose data.

Change from baseline in FSG was reported here. LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=133 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=142 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Change From Baseline in Fasting Serum Glucose (FSG)	-58.47 milligrams per deciliter (mg/dL) Standard Error 2.339	-43.64 milligrams per deciliter (mg/dL) Standard Error 2.269

SECONDARY outcome

Timeframe: Week 28

Population: All randomized participants with HbA1c, hypoglycemia and body weight data.

Percentage of Participants Achieving HbA1c \<7.0% With no Weight Gain (\<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=139 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=147 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Percentage of Participants Achieving HbA1c <7.0% With no Weight Gain (<0.1 kg) and Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)	51.8 Percentage of participants	21.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 28

Population: All randomized participants with HbA1c and hypoglycemia data.

Percentage of Participants Achieving HbA1c \<7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose \<3.0 mmol/L) was reported here.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=139 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=147 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Percentage of Participants Achieving HbA1c <7.0% Without Documented Symptomatic Hypoglycemia (Blood Glucose <3.0 mmol/L)	74.8 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 28

Population: All randomized participants with HbA1c and body weight data.

Percentage of Participants Achieving HbA1c \<7.0% Without Weight Gain (\<0.1 kg) was reported here.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=139 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=147 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain (<0.1 kg)	51.8 Percentage of participants	21.1 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 28

Population: All randomized participants with baseline and at least one post-baseline blood glucose data from SMBG profile.

The SMBG data was collected at the following 7 time points: Pre morning meal BG, 2-hour postprandial measurement for morning meal BG, Pre midday meal BG, 2-hour postprandial measurement for midday meal BG, Pre evening meal BG, 2-hour postprandial measurement for evening meals BG, and Bedtime BG. LS mean was determined using MMRM model with Baseline + OAM (metformin and/or acarbose) usage + HbA1c Group at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=125 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=132 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Change From Baseline in Blood Glucose From Daily Self-Monitored Blood Glucose (SMBG) Profile	-64.0 milligrams per deciliter (mg/dL) Standard Error 2.42	-37.7 milligrams per deciliter (mg/dL) Standard Error 2.36

SECONDARY outcome

Timeframe: Baseline, Week 28

Population: All randomized participants with a baseline and at least one post-baseline insulin glargine dose data.

LS mean was determined using MMRM model with Baseline + Baseline HbA1c strata (\<8.5%, \>=8.5%) + OAM use + Treatment + Visit + Treatment\*Visit (Type III sum of squares) as variables.

Outcome measures

Outcome measures
Measure	1.5 mg Dulaglutide n=133 Participants Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=143 Participants Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Change From Baseline in Daily Mean Insulin Glargine Doses	10.0 International Units per day(IU/day) Standard Error 1.045	14.0 International Units per day(IU/day) Standard Error 1.015

Adverse Events

1.5 mg Dulaglutide

Serious events: 8 serious events

Other events: 113 other events

Deaths: 0 deaths

Placebo

Serious events: 12 serious events

Other events: 99 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	1.5 mg Dulaglutide n=144 participants at risk Participants received 1.5 mg Dulaglutide administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.	Placebo n=147 participants at risk Participants received placebo administered QW SC as add-on to titrated TTT dose of insulin glargine given SC, along with metformin and/or acarbose.
Eye disorders Cataract	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Cataract nuclear	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Eye disorders Diabetic retinopathy	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Abdominal adhesions	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Appendicolith	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Chronic gastritis	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	1.4% 2/147 • Number of events 2 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Gastrointestinal disorders Large intestine polyp	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
General disorders Death	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholecystitis acute	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Hepatobiliary disorders Cholelithiasis	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Infections and infestations Appendicitis	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Brain stem infarction	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral haemorrhage	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebral infarction	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Cerebrovascular accident	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Nervous system disorders Dizziness	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Acute kidney injury	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Renal and urinary disorders Diabetic nephropathy	0.00% 0/144 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.68% 1/147 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.69% 1/144 • Number of events 1 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.	0.00% 0/147 • Baseline Through End of Safety Follow-Up (Up To 32 Weeks) All randomized participants. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.